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Classification: 42000000 [ADJ215003]

Preferred name 42 体外诊断技术
Definition 体外诊断包括作为试剂、试剂产品、校准器、控制材料、试剂盒、仪器、器械、设备或 系统使用的每一种医疗器械,单独或与其他器械组合使用,由制造商设计用于对来自人体的 样本(包括献血和组织捐献)进行体外检查,其唯一或主要目的是提供信息。这些信息可提供有关生理或病理状况或先天畸形的知识,或用于检测安全性和与潜在接受者的兼容性,或用于监测治疗措施。
IRDI 0173-1#01-ADJ215#003
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